FDA · United States
plerixafor — FDA regulatory status
plerixafor (PLERIXAFOR ARX) regulatory status in the United States is tracked from public FDA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: FDA approved.
Status snapshot
- Status
- FDA approved
- Brand
- PLERIXAFOR ARX
- Originator
- Lacuna Pharma Pty Ltd
- Mechanism
- C-X-C chemokine receptor type 4 partial agonist
- Target
- C-X-C chemokine receptor type 4
- Structured fields
- 8
Sponsor / originator context: Lacuna Pharma Pty Ltd. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: C-X-C chemokine receptor type 4 partial agonist. Target: C-X-C chemokine receptor type 4. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — FDA: approved.
Linked evidence on this spoke: 15 published clinical programs and 12 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| FDA | United States | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| CTX001-111 | Phase 3 | Vertex Pharmaceuticals (Australia) | 2024-516894-57-00 |
| OTL-103-4 | Phase 3 | Telethon Foundation | 2024-517792-20-00 |
| OTL-203-02 | Phase 3 | ORCHARD THERAPEUTICS | 2022-500306-17-00 |
| VX21-CTX001-141 | Phase 3 | Vertex Pharmaceuticals (Australia) | 2024-513349-35-00 |
| VX21-CTX001-151 | Phase 3 | Vertex Pharmaceuticals (Australia) | 2024-513978-22-00 |
| VX21-CTX001-161 | Phase 3 | Vertex Pharmaceuticals (Australia) | 2024-514641-12-00 |
| Busulfan Koanaa /ml Konzentrat zur Herstellun... | Phase 2 | Telethon Foundation | 2025-522160-32-00 |
| CTX001-121 | Phase 2 | Vertex Pharmaceuticals (Australia) | 2024-516067-83-00 |
| Plerixafor | Phase 2 | First People's Hospital | NCT06141304 |
| Plerixafor | Phase 2 | SANGAMO THERAPEUTICS | NCT03653247 |
| Plerixafor | Phase 2 | Cardiff Oncology | NCT01236144 |
| TEPADINA for Autosomal recessive osteopetros… | Phase 2 | Telethon Foundation | 2024-518972-30-00 |
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Related hubs
FAQ
What is the FDA approval status of plerixafor?
plerixafor currently shows FDA approved in our United States regulatory index. Confirm on the official FDA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get plerixafor regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to plerixafor?
This spoke lists 15 published programs associated with plerixafor in our pipeline index.